Clinical Trials in Small Scale Preparation

Question 1

What is the main Consequence of the Trials Directives?

Answer 1

To ensure the safety and efficacy of clinical trials

2004

• Identified what a clinical trial is, including products use
• Formalised ethics approval
• Outlined what is required when setting up, running and closing down a trial (Good Clinical Practice (GCP))

2006

• 1928 infringements
• 2984 consenet for incapacitated adults + emergency treatment

2008
- Consent for minors + emergency treatment

2014

• Improve harmonisation across europe
• Transparency of trial information
• Imported products-
• ‘auxilary’ medicinal products
• Hospital exemptions
  
  • > Re-labelling or re-packaging
  • > Preparation

Question 2

What is the main Consequence of the Trials Directive: 2004?

Answer 2

• Identified what a clinical trial is, including products use
• Formalised ethics approval
• Outlined what is required when setting up, running and closing down a trial (Good Clinical Practice (GCP))

Question 3

What is the main Consequence of the Trials Directive: 2006?

Answer 3

• 1928 infringements

- 2984 consenet for incapacitated adults + emergency treatment

Question 4

What is the main Consequence of the Trials Directive: 2008?

Answer 4

• Consent for minors + emergency treatment

Question 5

What is the main Consequence of the Trials Directive: 2014?

Answer 5

• Improve harmonisation across europe
• Transparency of trial information
• Imported products-
• ‘auxilary’ medicinal products
• Hospital exemptions
  
  • > Re-labelling or re-packaging
  • > Preparation

Question 6

What are the main steps in a Trial cycle?

Answer 6

1. Develop protocol
2. Get sponsor
3. Get Funding
4. Apply for Eudract Number
5. Apply for Clinical Trial Authorisation (CTA) & Ethics
6. Apply for Research approval
7. Carry out study (in compliance with GCP)
8. Notification of the end of the study
9. Submit report of study findings (documents maintained & archived)

Question 7

What is a ‘Type A’ trial?

Answer 7

The risk to the patient is considered to be no greater than that of standard medical care

These are trials involving medicinal products licensed in any EU Member State if:

• The trial relates to the licensed range of indications, dosage and form of the product
• The trial involves off-label use that is established practice and supported by enough published evidence/guidelines

Use the Notification Scheme

Question 8

What are the GMP requirements specific to IMPs?

Answer 8

Risk

• Healthy volunteers (phase 1) + patients (phase 2-4)
• Consistency between batches + adequate change control (knowledge around novel API will grow over time)
• Complexity with comparators, placebos, randomisation
• Incomplete knowledge of toxicity

Guidance of ordering,
shipping and returning

QMS

Personnel

Premises & Equipment

Documentation

Production

QC

Release of batches

Destruction

Question 9

When is it not an IMP?

Answer 9

• Non-investigational Medicinal Product (nIMPs)

- Reconstitution

Question 10

What are the Labelling requirements for clinical trials? (not needed if dispensing)

Answer 10

1. Name, address, telephone no, of sponsor, CRO or principle investigator
2. Dosage form, route of admin, quantity, potency
3. Batch number
4. Trial ref number
5. Trial subject id
6. Directions for use
7. ‘For clinical trial use only’
8. Storage conditions
9. Period of use
10. Keep out of reach of children

Question 11

What people are involved in IMP trials?

Answer 11

• Trial Sponsor
• Principle Investigator
• Clinical Research Organisation

Question 12

What Documentation is normally involved in IMP trials?

Answer 12

• Protocol
• Randomisation
• CTA
• Ethics
• R+D
• PSF
• Technical Agreements

Question 13

What is Reconstitution?

Answer 13

• Dissolving or dispersing the IMP for admin
• Diluting or mixing the imps with a vehicle

It is NOT
- Mixing several ingredients together, including the active substance to product the IMP